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Completed

NCT Number: NCT00731653

Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)

The objective of this study is to allow patients who have participated in the precursor study of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01) to receive 6 weeks of open-label treatment with an increased dose of BCI-024 in combination with an increased dose of BCI-049.

The safety and tolerability of this higher dose of the combination will be evaluated, as will the treatment effect in reducing symptoms of depression in patients with MDD.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Collaborative Neuroscience Network, Inc., Garden Grove, California, United States

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About this study

Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who are willing to provide written informed consent and who have completed participation in Protocol CBM-IT-01 are eligible for the study.
  • Eligible subjects will have demonstrated compliance with all CBM-IT-01's protocol requirements.

Exclusion criteria

  • Subjects who did not complete their participation in Protocol CBM-IT-01 are not eligible for the study.

Treatment and study plan

Combination Product: BCI-024 + BCI-049

Drug

BCI-024 and BCI-049 once a day at bedtime for 6 weeks

Primary outcomes

  1. The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.

    Time frame: Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • BrainCells Inc.

Registry information

Official study title

An Open-Label Extension Study to Assess the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Aug 11, 2008
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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